Cain, Kenneth D.

Patent Trials and Appeals Board

Sep 26, 2019

13570303 - (R) (P.T.A.B. Sep. 26, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/570,303 08/09/2012 Kenneth D. Cain 814.0051 8445
29085 7590 09/26/2019
HOWARD EISENBERG, ESQ.
200 Price Avenue
Elm #4
Narberth, PA 19072
EXAMINER
ZEMAN, ROBERT A
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
09/26/2019 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KENNETH D. CAIN
____________

Appeal 2018-008253
Application 13/570,303
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN,1 Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
This is a request for rehearing under 37 C.F.R. § 41.79 (“Req. Reh’g”)
of the Decision on Appeal entered June 17, 2019 (“Dec.”).
Appellant2 contends that the “Board mischaracterized the difference
between the disclosure/claims of Cain [’864] and the claims of the present
application.” Req. Reh’g 3.
We disagree.

1 Because of Judge Elizabeth A. LaVier’s unavailability, Judge Fredman has
replaced Judge LaVier who was on the panel that authorized the original
Decision of the Board. Cf. In re Bose Corp., 772 F.2d 866, 869 (Fed. Cir.
1985).
2 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as The Board of
Regents of the University of Idaho. Appeal Br. 3.
Appeal 2018-008253
Application 13/570,303
2
First, in addressing the obviousness-type double patenting and
obviousness rejections, the Decision focused on the differences the
Examiner identified between Cain ’864 and the rejected claims. Dec. 3.
Appellant has not directed us to where in the Appeal Brief or Reply Brief it
was argued that the Examiner had not appreciated the difference between the
rejected claims and Cain ’864. It appears that the only difference argued by
Appellant in the Appeal Brief is the same difference identified by the
Examiner, namely, the lack of disclosure of iron-limited medium by Cain
’864. Appeal Br. 13.
Second, even if the Examiner’s Answer and Decision did not
expressly identify all the differences between the claimed subject matter and
Cain ’864, Appellant has not provided an explanation as to how this alleged
deficiency would change the outcome of the Decision.

Cain ’864 and LaFrentz
Independent claim 4 is directed to a method of reducing morbidity
and/or mortality in fish due to disease caused by a bacterium comprising
administering “a live attenuated and a virulent derivative strain of the
bacterium.” The claim requires “live attenuated and avirulent derivative
strain that is administered has been grown, prior to the administering, in or
on a medium that is iron-limiting.” In dependent claim 5, “the disease is
coldwater disease caused by Flavobacterium psychrophilum.”
The Examiner found that it would have been obvious to one of
ordinary skill in the art to culture the Flavobacterium psychrophilum of Cain
’864 in iron-limited media prior to administration, as required by the
rejected claims, based on the teachings in LaFrentz that iron is limited in
Appeal 2018-008253
Application 13/570,303
3
vivo and that proteins expressed under iron-limiting conditions “‘may
represent potential vaccine candidate antigens.’” Dec. 3–4.
Appellant contends that the Board erred in determining that the
“combination of the Cain [’864] and LaFrentz references would . . . lead one
of skill in the art to the present invention.” Req. Reh’g 3. Appellant states
that the attenuated bacteria of Cain ’864 serve as effective vaccines against
Flavobacterium psychrophilum and include “the virulence determinants
and/or protective elements that are necessary to provide this protection.”
Req. Reh’g 5. For this reason, Appellant states that the skilled worker
“would not find it obvious to grow the vaccine of Cain [’864] in the iron-
limited media of LaFrentz in order to try to render the vaccine effective,
because it already is effective.” Id.
As indicated by Appellant, Cain ’864 discloses that protection against
coldwater disease (CWD) can be achieved using attenuated live
Flavobacterium psychrophilum. Cain ’864, col. 3, ll. 29–32. However, the
protection is not 100%. Cain ’864, col. 13 (Table 3 showing cumulative
percent mortality (CPM) and relative percent survival (RPS) after bacteria
challenge at the highest value is 40% and 45%, respectively (third row)).
Thus, one of ordinary skill in the art seeking to improve the vaccine
disclosed by Cain ’864 would have had reason to turn to the disclosure by
LaFrentz, which teaches that growing Flavobacterium psychrophilum under
iron-limiting conditions produces unique proteins that may have a role as
targets in vaccine development and as “vaccine candidate antigens.”
LaFrentz 172 (second column, first full paragraph), 175–176, 178. See also
LaFrentz 179 (last paragraph). As held in In re Peterson, 315 F.3d 1325,
1329–30 (Fed. Cir. 2003), there is a “normal desire of scientists or artisans
to improve upon what is already generally known.” Therefore, although
Appeal 2018-008253
Application 13/570,303
4
Cain ’864 teaches that its vaccines are effective, there is still room for
improvement in their efficacy (see Cain ’864 at column 13 described above)
and LaFrentz suggests an approach to do so. Accordingly, we are not
persuaded that “the skilled artisan would not find it obvious to grow the
vaccine of Cain [’864] in the iron-limited media of LaFrentz in order to try
to render the vaccine effective, because it already is effective.” Req. Reh’g
5.
Appellant also contends that the rejection is based on “impermissible
hindsight” because Cain ’864 teaches that its vaccine is “effective” and
“definitely must contain the necessary protective elements to confer
protection,” and thus there would be no reason to turn to LaFrentz. Req.
Reh’g 6–7; see id. at 4 (Appellant contends that “[i]t is only through the
impermissible use of hindsight that the Board, and the Examiner, have
concluded that the present claims are obvious in view of the cited prior art”).
This argument does not persuade us that we erred in the Decision. Appellant
admits:
The secondary LaFrentz reference discloses that whole
cell bacterial vaccines grown in standard iron-rich media do not
work because they lack the necessary protective elements to
confer protection. LaFrentz also discloses that bacteria grown
in iron-limited media produce several proteins at higher levels
than are produced when the bacteria are grown in iron-rich
media. LaFrentz concludes that it might be worthwhile to test
some of these proteins to see if they could be used as isolated
protein vaccines.
Req. Reh’g 6.
Thus, one of ordinary skill in the art would have had reason to
determine whether culturing the bacteria in iron-limited media, which
Appellant admits produce proteins under these conditions that “might be
Appeal 2018-008253
Application 13/570,303
5
worthwhile to test . . . to see if they could be used as isolated protein
vaccines,” enhanced vaccine efficacy. An explicit suggestion to modify the
prior art is unnecessary to establish obviousness. KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 415 (2007). As held by the U.S. Supreme Court in KSR
International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007):
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
Appellant further argues that “the Board has mis-comprehended
Appellant’s Brief on Appeal and Appellant’s Reply Brief.” Req. Reh’g 9.
Appellant asserts that it “never stated during the prosecution, or during this
appeal, that it should make little or no difference whether the bacteria cells
were grown in iron-limited media prior to administration.” Req. Reh’g 9.
In the Decision, it was stated:
Appellant also argues that the Examiner’s logic that it
would have been obvious to culture the bacteria in iron-poor
media is incorrect. Appeal Br. 15–16. Appellant contends it
“should make little or no difference” whether the bacteria were
cultured in iron-limited media prior to administration because
“after being administered, the bacteria would necessarily grow
in an iron-limited medium, and therefore, after growing for a
time within the iron-poor environment within the fish, they
would produce a similar protein expression pattern as would
bacteria that were grown in iron-limited media before
administration to a fish.” Id. at 16. Appellant argues that, in
contrast, the ’303 Application discloses “the unexpected
discovery” that the attenuated bacteria grown in iron-limited
media enhanced vaccine effectiveness as compared to a vaccine
already shown to be effective. Id.
Appeal 2018-008253
Application 13/570,303
6
Dec. 6 (emphasis added).
In other words, Appellant was arguing that it would not have been
expected that growing the bacteria in an iron limited medium prior to
administration would have enhanced vaccine efficacy because when the
bacterial cells were introduced into the fish, they would then be grown in the
iron-poor fish environment. Appellant now asserts that the Board
misconstrued what they said. This is incorrect. In the Appeal Brief,
Appellant stated:
If the Examiner’s logic were correct, then, because the
environment within a host fish is naturally iron-poor due to the
presence of iron-binding proteins within the host fish, it should
make little or no difference whether or not bacteria to be used
as a vaccine were grown in iron-poor media or iron-rich media
prior to being administered to the fish. This is because, after
being administered, the bacteria would necessarily grow in an
iron-limited medium, and therefore, after growing for a time
within the iron-poor environment within the fish, they would
produce a similar protein expression pattern as would bacteria
that were grown in iron-limited media before administration to
a fish.
(Appeal Br. 16 (emphasis added).)
The Examiner’s “logic,” according to Appellant, is that a host fish has
an iron-poor environment. Appeal Br. 15. Indeed, LaFrentz makes such a
statement: “[I]ron is limited in vivo due to host production of iron-binding
proteins.” LaFrentz 172 (first column). Appellant is arguing that “growing”
the bacteria in a fish after immunization would provide an iron-poor
environment, making the claimed prior iron-limited culturing step
unnecessary. We understood that this argument had to do with lack of
motivation to combine the publications, i.e., if iron is limited in the fish, then
once the fish had been immunized with the bacteria, the bacteria would
Appeal 2018-008253
Application 13/570,303
7
experience an iron-limited environment, making any prior culturing in an
iron-limited media superfluous. We considered this argument, but found it
unpersuasive. Dec. 6–7. Appellant has not identified a defect in our
response to the arguments set forth in the Decision.
Conclusion
Appellant’s Request for Rehearing is granted to the extent that we
have reconsidered our Decision in light of the arguments in Appellant’s
Request. Appellant’s Request is denied to the extent that we do not modify
the outcome of the Decision.

DENIED